As is well known in the art, various ECM based apparatus have been developed to regenerate tissue. Illustrative are the ECM based apparatus, i.e. grafts and endografts, disclosed in U.S. Pat. Nos. 7,795,027, 7,910,791, 7,905,826, and 8,025,896 and U.S. application Ser. No. 11/547,348.
The ECM material employed in the noted apparatus will, in most instances, induce host tissue proliferation, bioremodeling, and regeneration of tissue structures.
A major drawback of the noted ECM based apparatus, as well as most known apparatus, is that the means employed to secure the apparatus to tissue often comprise or include a permanent structure that remains in the body, i.e. non-biodegradable. As is well known in the art, such structures (or devices) can, and in most instances will, cause irritation and undesirable biologic responses in the surrounding tissue.
Such structures (and devices) are also prone to failure, resulting in severe adverse consequences, e.g., ruptured vessels.
A further drawback of known ECM apparatus is that the means employed to secure the apparatus to tissue is often ineffective. In the case of an ECM based endograft that is deployed in a cardiovascular vessel, if the endograft is not placed in intimate contact with the vessel wall, blood can, and in most instances will, pool between the endograft and vessel wall. The can result in severe adverse consequences, including vascular thrombosis.
There is thus a need for improved ECM based cardiovascular structures or constructs that employ biocompatible anchoring or securing means that effectively and safely secure cardiovascular structures, such as grafts and vascular prostheses, to biological tissue.
It is therefore an object of the present invention to provide ECM based cardiovascular structures, i.e. ECM constructs, having biocompatible anchoring means that effectively and safely secure the ECM constructs to biological tissue.
It is another object of the present invention to provide ECM constructs having biocompatible and biodegradable anchoring means that effectively and safely secure the ECM constructs to biological tissue, and, while engaged to the tissue, induce host tissue proliferation, bioremodeling and regeneration of new tissue, and tissue structures with site-specific structural and functional properties.
It is another object of the present invention to provide ECM constructs that deliver one or more biologically active agents, such as cells and growth factors, and/or one or more pharmacological or therapeutic agents to biological tissue when engaged thereto.
It is another object of the present invention to provide ECM constructs that can be readily employed to close and maintain closure of an opening in biological tissue, e.g. a surgical incision, and, if desired, also administer one or more biologically active agents and/or one or more pharmacological or therapeutic agents to biological tissue proximate the opening when engaged to the biological tissue.
As will readily be appreciated by one having ordinary skill in the art, the ECM constructs of the invention provide numerous advantages over conventional ECM based and non-ECM based apparatus for repairing and/or regenerating tissue. Among the advantages are the following:                The provision of ECM constructs that employ biocompatible and, in some embodiments, biodegradable anchoring means that effectively and safely secure the ECM constructs to biological tissue for a predetermined period of time;        The provision of ECM constructs that substantially reduce or eliminate (i) the harsh biological responses associated with conventional polymeric and metal ECM based and non-ECM apparatus, and (ii) the formation of inflammation and infection after deployment;        The provision of ECM constructs that can be readily and effectively employed to treat damaged or diseased biological tissue; particularly, cardiovascular tissue;        The provision of ECM constructs that can be readily employed to close and maintain closure of openings in biological tissue;        The provision of ECM constructs that induce host tissue proliferation, bioremodeling and regeneration of new tissue, and tissue structures with site-specific structural and functional properties; and        The provision of ECM constructs that effectively administer at least one biologically active agent and/or pharmacological agent or composition to a subject's tissue and, thereby produce a desired biological and/or therapeutic effect.        